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Clinical and Medico-economic Validation of the HEPHAI Solution.

NCT06099145 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2023-10-25

No results posted yet for this study

Summary

In a context where the use of inhalation devices for respiratory medications is associated with a high frequency of critical errors, our primary hypothesis is that the use of the HEPHAÏ solution reduces this frequency compared to standard care.

The objective of this clinical study is to evaluate the performance of the HEPHAÏ solution as a tool for improving the administration of inhaled treatments in patients undergoing pulmonary care for asthma and/or COPD, who are receiving treatment with Innovair® or Trimbow®. These two inhalers were chosen for reasons of feasibility and compatibility with the version of the HEPHAÏ software provided as part of the clinical investigation

Conditions

  • Asthma COPD

Interventions

DEVICE

Hephaï

Used of the HEPHAI medical device as a tool to improve the delivery of inhaled treatments for asthma and COPD

Sponsors & Collaborators

  • Hephai

    lead INDUSTRY

Principal Investigators

  • Capucine [email protected], Prof. · Department of Pneumonology, Pitié-Salpêtrière Hospital,

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-19
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099145 on ClinicalTrials.gov